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Diagnostic PET/CT Study with [AL[18F]F]FAPI-74 in Psoriasis Patients with Arthralgia for Early Detection of Psoriatic Arthritis

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

People with psoriasis often experience arthralgia, which is joint pain that can be an early sign of developing psoriatic arthritis. The study looks at a new imaging substance called [18F]-AlF-FAPI-74 that is given through a vein and then viewed with a special scanner known as PET/CT. The scanner creates pictures that show where inflammation is happening inside the body. These pictures are compared with images from power doppler ultrasound, another test that uses sound waves to see blood flow in joints.

The purpose of the study is to find out whether the PET/CT scan with the new tracer can detect early joint inflammation as well as or better than the ultrasound. Participants receive a single injection of the tracer, have a PET/CT scan, and also undergo an ultrasound exam of the affected joints. After the imaging visits, they are followed for up to two years to see if clinical signs of arthritis appear.

During the follow‑up period, doctors will check for new cases of arthritis and will compare the early imaging results with blood tests that measure inflammation, such as CRP and ESR. The study will also look at how the imaging findings match the number of painful joints and the level of pain reported by participants.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study Enrollment Confirmation

    You receive confirmation that you have joined the study and your participation is recorded.

    Your informed consent is documented, confirming that you understand the purpose and procedures of the trial.

  2. Step 2

    Baseline Clinical Assessment

    A physician records your medical history, current skin condition, and any joint pain you experience.

    Physical measurements such as tender joint count and pain scores are taken.

    Blood samples are drawn to measure inflammatory markers, including C‑reactive protein (CRP) and erythrocyte sedimentation rate (ESR).

  3. Step 3

    Injection of Imaging Tracer

    A radiopharmaceutical called [AL[18F]F]FAPI-74 is prepared as a solution for injection.

    The tracer is administered by an intravenous infusion at a dose of 3.5 megabecquerel per kilogram of body weight (3.5 MBq/kg).

    The infusion takes only a few minutes and is performed under medical supervision.

  4. Step 4

    PET/CT Scan

    Immediately after the tracer injection, you undergo a combined positron emission tomography and computed tomography (PET/CT) scan.

    The scan visualizes the distribution of the tracer in your body, allowing detection of subclinical inflammation in joints and surrounding tissues.

  5. Step 5

    Power Doppler Ultrasound Examination

    A specialist performs a power Doppler ultrasound of the joints that are most likely to develop arthritis.

    This non‑invasive imaging technique evaluates blood flow in the synovial tissue, which may indicate early inflammation.

  6. Step 6

    Follow‑Up Visits

    You return for scheduled follow‑up visits approximately every six months for up to two years.

    At each visit, the same clinical assessments (tender joint count, pain scores) and blood tests (CRP, ESR) are repeated.

    Additional power Doppler ultrasound examinations are performed to monitor changes over time.

    A repeat PET/CT scan with the same tracer dose may be scheduled during the follow‑up period, according to the study protocol.

  7. Step 7

    Study Completion

    After the final follow‑up visit, the study data are analyzed to determine whether the tracer imaging and ultrasound correctly predicted the development of psoriatic arthritis.

    You are thanked for your contribution and provided with a summary of the overall study findings.

Who can join the trial?

5 criteria

  • You must sign a written form showing you agree to take part in the study (this is called informed consent).
  • You must be older than 18 years.
  • If you are a woman, you must be either post‑menopausal, or surgically sterile (cannot have children), or you must be using an effective contraceptive and have a negative pregnancy test.
  • You must have a skin doctor (dermatologist) confirm that you have psoriasis, which can be one of these types: plaque psoriasis (raised red patches), guttate psoriasis (small drop‑like spots), or pustular psoriasis (pus‑filled blisters).
  • You must have ongoing joint pain (arthralgia) that is caused by inflammation, affecting the outer joints (peripheral joints) or the places where tendons attach to bone (entheses), lasting more than two weeks but less than two years, not due to an injury, and you must feel morning stiffness for at least ten minutes.

Who cannot join the trial?

12 criteria

  • You have or have ever had another type of inflammatory arthritis (joint inflammation) besides psoriatic arthritis.
  • You are already taking part in another clinical trial that uses a new drug or device that could interfere with this study.
  • You participated in a research study within the past year that gave you more than a small amount of radiation (more than 1 millisievert).
  • You are allergic (hypersensitivity) to the imaging drug used in this study, called [18F] AlF‑FAPI‑74, or to any of its inactive ingredients.
  • You are currently using strong medicines that suppress the immune system (systemic immunosuppressive therapy), such as biologic drugs (bDMARDs) or targeted disease‑modifying drugs (tDMARDs), for psoriasis or any other condition.
  • You have a condition that makes a PET scan unsafe or impossible, such as being pregnant or having severe claustrophobia (extreme fear of being in a scanner).
  • You have had a joint replacement surgery (for example, a knee or hip replacement).
  • You have another widespread skin condition, such as eczema (atopic dermatitis) or lupus (systemic lupus erythematosus).
  • You have ever had, or currently have, cancer (malignancy).
  • You are unable to understand the study, cannot give consent, or are not willing or able to follow all study procedures.
  • You have any other health problem that the doctor believes could put you at risk or make it hard to follow the study rules.
  • You are pregnant, breastfeeding, planning to become pregnant, or could become pregnant and are not using a reliable form of birth control (such as hormonal methods, intrauterine device, sterilization, etc.).
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Investigated drugs

[AL[18F]F]FAPI-74 is a special imaging agent that is injected into a vein during a PET/CT scan. It helps doctors see tiny changes in the skin and joints by lighting up areas where certain cells are active. In this study, the tracer is used to look for early signs of psoriatic arthritis in people who have psoriasis and joint pain, so that treatment can start sooner if needed.

What is already known about the treatment

[AL[18F]F]FAPI-74 - This medication is given as a solution for injection that is administered by intravenous infusion, typically at a dose of about 3.5 MBq per kilogram of body weight. It is an experimental radiopharmaceutical tracer that is still being studied and is not yet approved for routine clinical use. The tracer is used to help doctors see early signs of psoriatic arthritis in people with psoriasis who have joint pain, by attaching to a protein called fibroblast activation protein that is found on active tissue cells. It belongs to the class of PET imaging agents that contain a radioactive fluorine‑18 label.

Investigated diseases

  • Psoriasis

    A chronic skin condition that produces red, scaly patches, often on the elbows, knees, scalp, and lower back. The plaques may appear, disappear, and reappear over months or years. The disease can affect the nails, causing pitting or thickening. It typically begins in early adulthood but can start at any age. Environmental factors such as stress or skin injury can trigger flare‑ups.

  • Psoriatic arthritis

    An inflammatory joint disease that can develop in people who have psoriasis. It causes swelling, pain, and stiffness in the fingers, toes, spine, and larger joints. The joint involvement may start gradually and can spread to additional joints over time. Bone changes such as erosion or new bone formation may appear as the condition progresses. Symptoms can fluctuate, with periods of increased activity followed by quieter phases.

Trial detailsLast updated 18 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2026-526942-29-00Estimated enrolment270 patientsSponsorUZ Leuven

sourced from the EU Clinical Trials Register and site verification

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